State board says it can regulate compounding pharmacies

Andrea K. Walker, The Baltimore Sun

The state board that regulates Maryland pharmacies like the Massachusetts firm under investigation in a national fungal meningitis outbreak said it can adequately oversee so-called compounding pharmacies, despite cries from critics that the federal government should have more authority.

The Maryland Board of Pharmacy said last week that in the last four years it has beefed up oversight of compounding pharmacies, which make drugs not sold commercially. New safeguards including random, annual inspections would make it hard for a Maryland facility to reach the level of contamination problems found at the New England Compounding Center, said Laverne Naesea, the board's executive director.

The 19-state fungal meningitis outbreak that sickened 438 and killed 32 is linked to three lots of steroids mixed at the New England Compounding Center. In Maryland, 23 people have been sickened and 1 has died. Federal investigators found mold, bacteria and other contamination problems at the facility.

The case prompted calls to give the Food and Drug Administration more authority over the regulation of the facilities, which are now under the jurisdiction of state boards. Some lawmakers and advocacy groups have argued the state boards don't have the resources to guarantee the safety of compounding pharmacies.

While no place is totally immune from harm, what happened in Massachusetts is unlikely to occur in Maryland facilitiesbecause of the safeguards that are in place, Naesea said. New England Compounding acted more as a large manufacturer, which is against state law, she said. Investigators in Maryland would be able to see signs of a company becoming too large, she said.

Inspections should also catch problems with cleanliness and sanitation at the state's 99 compounding pharmacies, Naesea added.

"It could happen anywhere depending on how deviant the practitioner is," Naesea said of the meningitis contamination. "But here in Maryland, compounding facilities are monitored fairly closely.

At least one board member said increased FDA oversight also would come with complications.

"There are so many of them [compounding pharmacies] and they are so small, oversight would be difficult," said David Ross Chason, a commissioner with the Maryland Board of Pharmacy.

Maryland was among 34 states that Massachusetts Rep. Edward J. Markey said in a recent report had "problematic" compounding practices and lax oversight.

The report listed four incidents in which Maryland was confronted with tainted drugs from compounding pharmacies. In one case, 16 patients contracted hepatitis C from a contaminated drug used for heart imaging, and in another an Annapolis pharmacy was using drugs with an ingredient that caused cardiac problems in patients in other countries.

The FDA also cited a Lanham company for distributing a drug that causes sterility to Maryland hospitals and clinics and a Minnesota company for selling drugs to Maryland hospitals and clinics that could lead to blindness.

All those incidents happened in 2004 and 2005, and members of the pharmacy board pointed out the FDA hasn't issued any more warning letters since the state strengthened oversight of the facilities in 2008.

That year, the state began using standards it adopted from the U.S. Pharmacopeial Convention, a group that sets voluntary drug safety standards. Under the new guidelines, Maryland's compounding pharmacies must meet requirements of general pharmacies, as well as separate ones for compounding facilities.

The requirements for compounding facilities fall under 11 categories that include proper training of employees in sterile preparation procedures, cleaning standards for rooms where drugs are made and proper disposal of waste.

In October, the board strengthened the laws even further by requiring out-of-state compounding facilities selling to Maryland hospitals and clinics to meet Maryland laws and have at least one pharmacist licensed in the state. Before that Maryland could only investigate a complaint if the home state didn't take action.

"The board is extremely proactive in trying to prevent problems from occurring," Naesea said.

Still, in light of the meningitis incident, the pharmacy board said it is looking at other ways it can boost oversight. It is exploring requiring additional data from compounding pharmacies about their volume and credentials and whether to conduct additional inspections. It also is looking to further increase oversight of out-of-state boards.

But proponents of more government oversight said even the strongest state programs could use more support from the federal government. Congressman Markey said the meningitis case shows that state boards can't control cases that don't originate locally.

"Because the compounding business involves shipping drugs across state lines, the federal government — specifically the FDA — should have increased authority to keep patients safe who rely on compounded drugs," Markey said in a statement. "We need federal legislation that strengthens FDA regulations for the compounding pharmacy industry to help ensure that legal loopholes are not exploited to the detriment of patient health."

Maryland state epidemiologist Dr. David Blythe said during a legislative hearing on compounding pharmacies last week that state regulations need to be reviewed in light of the meningitis case.

"The Maryland Board of Pharmacy is committed to doing everything it can to protect Maryland residents from unsafe, compounded drugs," said Blythe, according to written testimony from the hearing.

Health Secretary Joshua M. Sharfstein argued for more of a federal role in a recent New England Journal of Medicine article. He wrote that ideally the FDA would set regulations for these pharmacies and the states would play a supportive enforcement role.

In a phone interview, he said: "I don't think states alone can do it because this is a national health challenge. I think that states are an important partner, but there needs to be a national framework."

One national patient advocacy group, Public Citizen, said that the meningitis case shows weakness throughout the system, both at a local and national level. The state of Massachusetts previously found problems at the New England Compounding, but it was allowed to remain open.

Public Citizen said it would support minimum standards that all states would have to use to regulate compounding pharmacies. It also wants the pharmacies to clearly state that their drugs are compounded and not approved by the FDA.

"The failures in the meningitis incident was multi-level," said Dr. Michael Carome, deputy director of Public Citizen's health research group. "There were so many opportunities to intervene and prevent this tragedy."

The Maryland Board of Pharmacy issued letters to five compounding facilities in fiscal year 2012 because of problems found in their facilities. The pharmacies, which included Johns Hopkins Bayview Medical Center Inpatient Pharmacy — were ordered to correct the problems.

Johns Hopkins Bayview was cited because its "clean room" where drugs are mixed did not meet state standards. It lacked air pressurization, contained windows that were kept open, had floors that were not properly sealed, and the seats on the chairs in the room had ripped covers and exposed foam, according to documents.

The hospital fixed the problem or showed that in some cases they actually were in compliance, the documents said.

"During a routine Board of Pharmacy inspection, deficiencies were cited in the pharmacy environment," the hospital said in a statement. "Immediate actions were taken and full compliance was achieved. At Johns Hopkins Bayview Medical Center, patient safety is the top priority and recommendations from the Board of Pharmacy and other accrediting organizations are routinely implemented into our extensive safety and quality improvement programs."

Naesea said the board's goal is to work with the pharmacies.

"A lot of people think we should be shutting down pharmacies," Naesea said. "We want them to practice correctly and not harm anyone."